- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03197207
Quantitative Analysis of Different Acupuncture Needle Manipulation to Treat Chronic Shoulder Pain
June 22, 2017 updated by: Chang Gung Memorial Hospital
The plan " Quantitative analysis of different acupuncture needle manipulation to treat chronic shoulder pain "includes an objective observation of acupuncture operation (movement in the form of acupuncture needles, intensity, etc.) and the body (acupoints) reactions.
Patients during 20-55 years old suffered shoulder pain more than six weeks with numerical rating scale (NRS) pain intensity more than 5 points, and the previous month were not taking medicine or Western medicine were included.
Then use of distal acupoints GB34 and GB39, giving once acupuncture manipulation therapy.
Study Overview
Status
Completed
Conditions
Detailed Description
Numerical rating scale (NRS) and pain pressure algometer were used to objective and quantitative assessment of the patient's pain.
And shoulder pain and disability index-SPADI was used to objectively assess the functional changes of acupuncture treatment in patients with chronic shoulder pain.
Massachusetts General Hospital Acupuncture Sensation Scale - MASS was used to get objectively record of de-qi when needle manipulation for the the body (acupoints) reactions.
Acusensor2 was used to get objective observation reaction during needling manipulation, the sensor provided measurement parameters such as the lift and thrust, twisting, strength and torque during needle manipulation.
Investigators will study and analysis associated clinical outcome with needling process, the needle manipulation by lifting-thrusting or twisting-rotating during the process of reinforce method or reducing method to study its dynamics and kinematics.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- (A) have agreed to participate in the trial and signed by the Chang Geng Memorial Hospital Human Body Test Committee approved the human test consent.
- (B) suffering from chronic shoulder pain (including frozen shoulder, or rotator cuff injury, or subclavian bursitis, Or biceps tendonitis or nonspecific shoulder pain).
- (C) at least six weeks before the screening period of shoulder pain, digital grading scale measurement of pain intensity of 5 points or more.
Exclusion Criteria:
- (A) shoulder fracture
- (B) intra-articular infection
- (C) stroke hemiplegia
- (D) spinal cord injury
- (E) postoperative shoulder surgery
- (F) pregnant woman,
- (G) took traditional Chinese medicine or Western medicine, less than one month before the screening period
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: lifting and thrusting
"Dragon and Tiger warring" in lifting and thrusting
|
"Tight press" slow insert in each acupoint through the superficial,intermediate, deep layer, then "tight lifting" slow withdraw needle through the deep, intermediate, superficial layer .
Two acupoints (GB34, GB39) are manipulation in the process three times each during one minute, then let patients lift shoulder up and down for three times, then draw out the needle 20 minutes later.
|
Experimental: twisting and rotating
"Dragon and Tiger warring" in twisting-rotating
|
When needle insert in each acupoint through the superficial,intermediate, deep layer, within each layer twisting thumb forward nine times, then twisting backward six times.
Two acupoints (GB34, GB39) are manipulation in the process during one minute, then let patients lift shoulder up and down for three times, then draw out the needle 20 minutes later.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Numerical rating scale (NRS) during needle manipulation
Time Frame: Through study completion, an average of 5 minutes.
|
Pain scale, smaller score, less pain.
NRS in T0(before needle manipulation), T1(after GB34 "de-qi" ), T2(after GB34 "Dragon and Tiger warring" ), T3(after GB39 "de-qi" ), T4(after GB39 "Dragon and Tiger warring" ), T5(after Retaining Needle 20 minutes), T6(Telephone access, 24 hours later)
|
Through study completion, an average of 5 minutes.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Pain pressure algometer (PA) during needle manipulation
Time Frame: Through study completion, an average of 5 minutes.
|
The higher the score, the greater the strength that can be tolerated.
PA in T0(before needle manipulation), T1(after GB34 "de-qi" ), T2(after GB34 "Dragon and Tiger warring" ), T3(after GB39 "de-qi" ), T4(after GB39 "Dragon and Tiger warring" ), T5(after Retaining Needle 20 minutes)
|
Through study completion, an average of 5 minutes.
|
Change in Massachusetts General Hospital Acupuncture Sensation Scale (MASS) during needle manipulation
Time Frame: Through study completion, an average of 5 minutes.
|
objectively measure sensation associated with 'de qi' sensation.
MASS in T1(after GB34 "de-qi" ), T2(after GB34 "Dragon and Tiger warring" ), T3(after GB39 "de-qi" ), T4(after GB39 "Dragon and Tiger warring" )
|
Through study completion, an average of 5 minutes.
|
Change in Shoulder Pain & Disability Index (SPADI)
Time Frame: Through study completion, an average of 10 minutes.
|
13 items that assess two domains, 5-item subscale that measures pain, 8-item subscale that measures disability.
T0(before needle manipulation), T5(after Retaining Needle 20 minutes), T6(Telephone access, 24 hours later)
|
Through study completion, an average of 10 minutes.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Acusensor2, Needle manipulation parameters
Time Frame: Through study completion, an average of 5 minutes.
|
Measurement of lift and thrust, twisting, strength and torque during needle manipulation.
The real-time motion and force tracings records created during needle manipulation will be combined to report needling motion and force profiles pictures.
Displacement (mm), Rotation (rev), Force (mN), Torque (microNm).
Ta(during GB34 "Dragon and Tiger warring" ), Tb(during GB39 "Dragon and Tiger warring" )
|
Through study completion, an average of 5 minutes.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Horng-Sheng Shiue, Dr., Chang Gung Memorial Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 3, 2016
Primary Completion (Actual)
August 25, 2016
Study Completion (Actual)
December 30, 2016
Study Registration Dates
First Submitted
May 11, 2017
First Submitted That Met QC Criteria
June 22, 2017
First Posted (Actual)
June 23, 2017
Study Record Updates
Last Update Posted (Actual)
June 23, 2017
Last Update Submitted That Met QC Criteria
June 22, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pain
- Neurologic Manifestations
- Joint Diseases
- Musculoskeletal Diseases
- Arthralgia
- Shoulder Pain
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents, Local
- Anti-Infective Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Dermatologic Agents
- Antipruritics
- Salicylates
- Methyl salicylate
- Menthol
- Camphor
Other Study ID Numbers
- 105-0313C
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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